Group Head MSAT Equipment Qualification 80-100%

Lonza; Schweiz; On-site; Vertraulich; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Competitive compensation programs

Variety of benefits depending on role

Job summary

Lonza is seeking a leader to head the Equipment Qualification & Process Platforms function at our Stein, AG site, Switzerland. You will manage people, resources and delivery across MSAT, shaping qualification strategies for sterile drug manufacturing technologies.

With a MSc/PhD in a relevant field, you will drive process platforms, SUS governance, and lifecycle strategies, collaborating across PHAD, MSAT Tech Transfer, Engineering and Operations to ensure top quality and regulatory compliance.

Qualifications

• MSc or PhD in Pharmaceutical Sciences, Pharmaceutical Engineering, Chemistry, Bioengineering, Biochemistry, or a related discipline.
• Solid experience in sterile drug product (fill & finish) manufacturing environments is a must.
• Demonstrated expertise in equipment qualification, lifecycle management, process validation, and aseptic manufacturing technologies.
• Strong knowledge of GMP and regulatory requirements, with experience supporting regulatory inspections.

Responsibilities

• Lead the Equipment Qualification & Process Platforms function with accountability for people, resources, capabilities, priorities, performance and delivery.
• Build and develop MSAT expertise through resource planning, coaching, talent development and succession planning.
• Set the strategic direction for Equipment Qualification and Process Platform activities, translating priorities into objectives and capability plans.
• Ensure capability and governance for sterile-manufacturing technologies, including isolator tech, decontamination, sterilization, filling and closing systems and freeze-dryers.
• Provide governance for Drug Product Process Platform ownership, ensuring lifecycle strategies for thawing, compounding, filtration, filling, stoppering and related tech.
• Ensure capabilities and governance for Single‑Use Systems are established to support site and business needs.
• Establish MSAT governance framework and standards for Equipment Qualification and Process Platforms, aligning with GMP and Lonza standards.

Skills

Sterile manufacturing

Equipment qualification

Lifecycle management

Process validation

Aseptic tech

GMP knowledge

Education

MSc or PhD in Pharmaceutical Sciences/Engineering/Chemistry/Biochem

Job description

The actual location of this job is in Stein, AG, Switzerland . Relocation assistance is available for eligible candidates and their families, if needed.

Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong.

Make a lasting impact by leading a high-performing team responsible for the qualification, governance, and continuous development of critical sterile manufacturing processes and technologies. As the technical authority for equipment qualification and process platform ownership, you will define lifecycle strategies that ensure compliance, reliability, and manufacturing robustness. You will also drive the evolution of process platforms and single-use systems, strengthening standardized capabilities that support current and future business needs. Check out Your Career in Drug Product Services at Lonza !

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.


• An inclusive and ethical workplace.


• Compensation programs that recognize high performance.


• A variety of benefits dependent on role and location.


• The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits


• Our local benefits can be found here: 3cf206339e0e4e41a77e8c806138c2b5

What you will do:

Lead the Equipment Qualification & Process Platforms function, with accountability for people, resources, capabilities, priorities, performance and delivery. Build and develop the required MSAT expertise through effective resource planning, coaching, talent development and succession planning.

Set the strategic direction for Equipment Qualification and corresponding Process Platform activities, translating site and business priorities into functional objectives, capability plans, and ensuring effective delivery through the MSAT expert organization. Provide MSAT functional leadership for equipment qualification, ensuring that process, product and manufacturing requirements are appropriately translated into qualification strategies and that the required MSAT expertise is deployed to support critical sterile drug product manufacturing equipment throughout its lifecycle.

Ensure appropriate capability and governance for critical sterile‑manufacturing technologies, including isolator technology, H₂O₂/VHP decontamination, thermal sterilization, filling and closing systems and freeze‑dryers, deploying specialized MSAT expertise according to site and business priorities.

Provide functional leadership and governance for Drug Product Process Platform ownership, ensuring appropriate technical ownership and lifecycle strategies are established for Drug Substance thawing, compounding and mixing, sterilizing filtration, filling, stoppering, crimping and associated manufacturing technologies.

Ensure the required capabilities, expertise and technical governance for Single‑Use Systems (SUS) are established and maintained within the function to support site and business needs.

Establish and maintain the MSAT technical governance framework and standards for Equipment Qualification and Process Platforms, ensuring alignment with GMP and regulatory expectations, Lonza standards and relevant industry practices, and driving harmonization where appropriate. Represent the function as the senior MSAT technical authority for Equipment Qualification, Process Platforms and SUS in cross‑functional governance, customer interactions, audits, regulatory inspections and Health Authority engagements as ...

Drive the strategic development and continuous improvement of the function, strengthening technical capabilities, standardization, knowledge management and adoption of new technologies to support manufacturing robustness, operational performance and future business needs. Establish strong partnerships with PHAD, MSAT Tech Transfer, Engineering, Operations and relevant Lonza global functions, including Global Operations, Material Excellence and the DS network, to drive harmonization with global standards, strengthen the DS/DP interface, and ensure aligned equipment qualification and process platform strategies across the product lifecycle.

What we are looking for:

• MSc or PhD in Pharmaceutical Sciences, Pharmaceutical Engineering, Chemistry, Bioengineering, Biochemistry, or a related discipline,


• Solid experience in sterile drug product (fill & finish) manufacturing environments is a must.


• Demonstrated expertise in equipment qualification, lifecycle management, process validation, and aseptic manufacturing technologies, with a strong understanding of process platforms and single‑use systems.


• Strong knowledge of GMP and regulatory requirements, with experience supporti